EUCTR2014-005367-32-IT进行中（未招募）1 期
PROTEIN MISFOLDING, AMYOTROPHIC LATERAL SCLEROSIS AND GUANABENZ: A PHASE II RCT WITH FUTILITY DESIGN - PROMISE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 208
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Diagnosis of, probable, probable laboratory supported or definite sporadic (SALS) or familiar (FALS) ALS according to the revised El Escorial criteria; 2) age >18 yrs; 3) onset =18 months before randomization; 4) sVC =70% in spinal onset; 5) riluzole 100 mg/day or no riluzole; 6) written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 166
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •1) PEG, NIV or tracheotomy; 3) known heart, renal or liver failure; 3) known intolerance to alfa2agonists; 4) known conditions at risk for cardiovascular disorders or symptomatic hypotension; 5) participation in a clinical trial within 3 months prior to the screening; 6) cognitive impairment defined by the Edinburg Cognitive and Behavior ALS Screen (ECAS) scale
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